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Start for FreeRoberto Gomez
Director of Quality @Outset Medical, Inc.
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WORK HISTORY
Director of Quality @Outset Medical, Inc.
Tijuana, MX
EDUCATION
Universidad La Salle Noroeste, A.C.
Quality Industrial Engineer, Industrial Engineering
ABOUT ROBERTO GOMEZ
Seasoned manufacturing, engineering and quality expert with over 19 years in process validation for Transfers and NPI, equipment management, and Six Sigma projects. Proven leader in startup operations, cost reduction, and regulatory compliance. Adept at statistical analysis, problem-solving, and quality system management. Recognized for enhancing efficiency and driving continuous improvement across multiple sites. More than 10 years as manager.Core proficiencies:• Communication• Problem Solving• Risk Management• Basic and Advanced Statistical Analysis• Manufacturing Processes• Packaging (F/F/S)• Leadership• Validation Protocols and Reports• Software Proficiency• Financial Forecasting• Process ImprovementAwards and Certifications:• ASQ Certified Manager of Quality / Organizational Excellence (CMQ / OE).• ASQ Certified Six Sigma Green Belt (CSSGB).• ASQ Certified Quality Engineer (CQE).Qualifications and Skills:• Bilingual (Spanish and English).• Servant Leadership and administration of resources.• Financial Forecast for HC and Budgets (discretionary expenses). Monthly and Quarterly Variation Reports (P&L).• Vast experience with Problem-Solving Quality Techniques.• Risk Management Assessments. PFMEA and Control Plans.• Solid career experience in Engineering and Quality Department. Experience with EO and Gamma Sterilization.• Experience writing and executing MVP, FAT-SAT, MSA (GR & R), IQ, OQ and PQ Protocols / Reports. Lead Software Validation Quality Engineering Department.• Vast Statistical Analysis experience: DOE, MSA, SPC, ANOVA, Variance Tests, Medians Test, Cpk/Ppk, Cpm/Ppm.• Cost Saving Projects by applying Six Sigma (DMAIC).• High experience in manufacturing for manual, semi-automated and automated processes. Also, solid experience in molding, extrusion and packaging.• Computer Software Knowledge: Minitab Solutions, MS Applications, Quality Document Management System, Basic knowledge on ERP systems such as SAP and BPCS.• Leadership, work team, motivated, exceptional ability to learn new skills, efficient and urgent sense.
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